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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K121590
Device Name VESTIBULAR ANALYSIS APPARATUS
Applicant
CAPACITY SPORTS, LLC
2800 PLEASANT HILL
SUITE 175
PLEASANT HILL,  CA  94523
Applicant Contact PAMELA M BUCKMAN
Correspondent
CAPACITY SPORTS, LLC
2800 PLEASANT HILL
SUITE 175
PLEASANT HILL,  CA  94523
Correspondent Contact PAMELA M BUCKMAN
Classification Product Code
LXV  
Date Received05/31/2012
Decision Date 09/20/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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